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Investing.com -- Shares of MaaT Pharma surged 7% today following the Data Safety Monitoring Board’s (DSMB) final validation of the company’s leading drug candidate, MaaT013, for the treatment of acute Graft-versus-Host Disease (aGvHD).
The DSMB’s endorsement, which was largely anticipated by the market, comes after the announcement of strong results from the ARES Phase 3 trial in January. MaaT013 demonstrated "remarkable efficacy" in the final 66 patients of the study, reinforcing its strong benefit/risk profile.
The pivotal ARES Phase 3 study had already exceeded expectations with a 62% gastrointestinal Overall Response Rate (GI-ORR) at day 28, surpassing the anticipated 38%. Furthermore, the trial showed a 54% survival rate at one year, indicating a significant survival benefit in a patient population with very poor prognoses.
The company has now set its sights on submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June 2025, with a potential launch expected by mid-2026. MaaT Pharma is also keeping a close eye on its cash position, ensuring a runway until the second quarter of 2025, while exploring partnership opportunities.
Analyst from Stifel commented on the company’s strategic position: "We believe that the 40+ sites covered during the Expanded Access Program should enable MaaT Pharma to handle commercialisation alone, while we expect them to find a partner in the US."
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